In June 2017, the new Food and Drug Administration (FDA) commissioner Scott Gottlieb pre-announced his agencys Digital Health Innovation Action Plan that indicates notable shifts in the agencys approach to digital health technologies. This plan is an important step in FDA regulation of this area, a process that began in 2011 with a draft guidance, followed by significant congressional actions. The new changes should not be surprising, given critiques published by Gottlieb prior to re-joining the FDA. In 2014, he wrote that smartphones are purposely dumbed down due to the risk of unwieldy FDA regulation, and in 2015, he argued that what most considered the FDAs light touch on digital health was still too heavy-handed. The new plan signals two major shifts: first, a shift from premarket to postmarket review by the FDA; and second, a shift from oversight by the FDA to oversight by independent, nongovernment certifiers. These changes may be bellwethers for how a Trump-era FDA approaches areas far beyond digital health.

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